It is very difficult to measure the problem of counterfeiting accurately from year to year – by definition criminals don’t
file tax returns or publish quarterly earnings. Data compiled by the Pharmaceutical Security Institute seem to show only a
small increase in reported counterfeiting incidents during 2010 (1), but there are many caveats. The breakdown of the same
data by region implies that Africa has around 2% of the counterfeit problem (2), but as the PSI acknowledges, this is likely
to be an underestimate due to lack of enforcement infrastructure. In my opinion, formed by travelling in the region and by
talking to local regulators and those working in the field, such as Roger Bate, Paul Newton and others, there is a largely
unreported tragedy occurring in Africa and other developing regions because of the high prevalence of fake and substandard
Mark Davison is CEO at Blue Sphere Health Ltd and the author of Pharmaceutical Anti-Counterfeiting: Combating the Real Danger
from Fake Drugs and Pharmaceutical Serialisation: Opportunity or Perfect Storm.
With the EU’s Falsified Medicines Directive and similar legislation under discussion in the US, legislators are at last moving
to tighten the security of the drug supply chain in our developed economies. However, we need to remember that medicine is
global and so is organised crime. Drug-resistant pathogens are emerging in Africa and Asia, partly due to the use of counterfeit
sub-potent drugs supplied by international crime syndicates, and there is potential for these resistant forms of previously
treatable diseases to spread to Europe and the US. As well as our moral obligation to help, enlightened self-interest should
encourage us to equip developing nations with the necessary tools to protect themselves against fake drugs.
At Blue Sphere, we spend much of our time advising companies on technology choice and implementation, so we see a lot of proposals
and claims from vendors. Many of these technologies are excellent (and I discuss the key approaches in my book “Pharmaceutical
Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”, Wiley, 2011) but none are a “solution” on their own. In general,
we advise companies to use a layered approach combining several different security technologies. In our view, all packs should
carry at least one covert technology, such as taggants, and a traceability data carrier such as a 2D barcode. These two features
can often be applied in one combined step. Packs should also have tamper-evident security seals wherever feasible.
There will always be new technologies coming along that claim to be counterfeit-proof, but the key is wide-scale implementation.
The need for new technologies is less critical than the need to universally adopt what we already have.
Securing the packaging
Packaging security is still critical. Digital traceability systems, whether full track and trace or end-to-end verification
as proposed by EFPIA and others, are only one element of security. A visible printed code can be copied easily and the copy
is indistinguishable from the original unless additional features are present on the pack or in the physical features of the
code itself. However, there are many challenges in putting physical security on packs: available space, tools needed for verification
etc. In Europe, where repackaging is common, a feature on an outer box may be discarded during parallel trade. The closer
the authentication feature is to the active ingredient the less likely it is to become dissociated from the product during
transit through the supply chain. We work with our customers to devise secure, risk-adjusted strategies that are compliant
with upcoming regulations without breaking the bank.